What's a White Paper and how is one applicable in the Medical Device field?

S

Silvertabb

#1
What's a white paper? Does it have any legal basis? In what instances should you use it for your devices? Why are companies generate white papers? Any other explanation would be appreciated.

Thanks!
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Re: What's a White Paper?

Can anyone tell us how "White Paper" is used (etc) in the context of Medical Device Manufacturers?
 

Jim Wynne

Staff member
Admin
#5
Re: What's a White Paper?

Can anyone tell us how "White Paper" is used (etc) in the context of Medical Device Manufacturers?
I don't know much about medical devices in general, but there's a fairly large collection of related white papers at Qmed that might shed some light. At a glance it looks like it's mostly about marketing.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Re: What's a White Paper?

Thanks for taking a look, Jim. I appreciate it. Medical Devices is way off my areas of experience, too.
 

Wes Bucey

Quite Involved in Discussions
#7
In my experience as a consultant to some medical device companies, I've seen several "white papers." Jim Wynne is correct in that at heart they are marketing devices. The premise is to generate an "apparently" unbiased description or survey of a "problem," give a brief description of a range of devices which purport to provide a solution for the problem and then, as part of the description of the devices, present one's own device as doing one or more of the following:

  1. solve a wider range of problems
  2. be more efficacious in solving a particular problem
  3. do the same as every other device, only far less expensively.
Often, the prose turns a little purple and the so-called "advantages" are meaningless. There are often references to studies, polls, experiments, etc., but the bottom line is the folks who present the white paper are looking to sell something - this is NOT altruism at work. The over-riding hallmark of a white paper is that it rarely, if ever, denigrates a competing product, it just shows that the "sponsored product" has a "better" solution.

This link (http://www.slideshare.net/organprinter/preors-bone-anchor-presentation) goes to a "powerpoint white paper" of 25 slides - my guess is the guys who wrote this are looking to interest orthopedic surgeons into trying and buying their design.
 

pkost

Trusted Information Resource
#8
Answering whether white papers have any legal basis, I can only cover the UK with any certainty, but I would strongly suspect that my understanding is standard across the majority of countries,

Essentially white papers do not have any legal standing within the uk, and almost certainly the EU as that would not be in keeping with the medical device directive. From a design perspective I generally find them to contain heavily biased marketing drivel (at least commercial ones), which can at best be misleading. I understand they are more beneficial on the marketing side as they can give an understanding of the potential of a market, but you still have to question where the author gets the data and whether it is accurate.

Although white papers have no legal standing, government commissioned ones may in the longer term have an effect on a medical device business. Although the government (UK) cannot ignore the MDD, it can issue directions to the state run NHS and the various department of health quangos can write and commission their own white papers. I can't think of any examples of this though
 
M

MIREGMGR

#9
The US FDA considers marketing-oriented "white papers" to be "labeling", and therefore considers statements and claims within such white papers to be subject to regulation. This is true for all areas of FDA jurisdiction as far as I know...certainly pharma, devices and biologicals, and I think food as well.
 

pkost

Trusted Information Resource
#10
Ah, I hadn't thought of it from that perspective! The same would probably apply in the EU if you the manufacturer is writing the white paper on their own device/product.
 
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